Ventriculo-venous shunt device for treatment of hydrocephalus



Nov. 5, 1963 s. SCHWARTZ 3,109,429

VENTRICULO-VENOUS SHUNT DEVICE FOR TREATMENT OF HYDROCEPHALUS Filed Jan. 50, 1962 llllll 2 25 l #1 9 l2 l2 E 37 34 F D E 25 c B as INVENTOR. SAMUEL SCHWARTZ ailkow oavmu.

ATTORNEYS United States Patent 3,19%429 VENTRICULG-VENGUS SHUNT DEVICE Fill? TREATMENT CF HYBFLOCEPHMLUS .damuel Schwartz, 3428 Fayette St, Philadelphia t), Fa. Filed Jan. 36, 1952, Ser. No. 169,784 9 Claims. (Cl. 128--35ll) This invention pertains to apparatus for the treat ment of hydrocephalus by directing cerebrospinal fluid into another area of the body such as the circulatory system. More particularly, it relates to a normally-open unidirectional flow apparatus which may be included in a surgical shunt such as one established between a lateral ventricle and the internal jugular vein or between lateral ventricle and right auricle.

The theory of treating communicating or obstructive hydrocephalus by establishing communication between the cerebrospinal fluid pathways and the vascular system was first suggested by Gartner in 1895. Practical operative techniques had to await the development of check valve structures for inclusion in surgically created shunts. The history of these developments is described by Pudenz, R. H. et al. in Journal of Neurosurgery vol. 14(2), March 1957, pp. 171-179 and by Pudenz, R. H. et al. in Clinical Neurosurgery vol. 5, 1957(1958), pages 98- 114, which articles are incorporated herein by reference.

A widely used valve for such operations is that de scribed in US. Patent #2,96 9,(l66 which issued on January 24, 1961 to Holter et al. This valve, which =represented a step forward over the prior art, has disadvantages. See Talner, N. 3., et al., Thromboeimbolism Complicating Holter Valve Shunt Amer. ll. Dis. Child. 101:602-609, May 1961; Callaghan, R. P. et al., Septicaemia Due to Colonization of Spitz-Holter Valves by Staphylococci British Medical Journal 5229: 860 -3, March 25, 1961; and Corlett, K, Septicaemia and Meningitis in Hydrocephalus; Report of a Case Cornplicating Ventriculo-Atrial Shunt with a Spitz-Holter Valve New Zealand Medical Journal 59:54-9-551, November 1 960. Also, the valve requires difi'erential pressures in excess of 30* mm. of water to open.

In designing such apparatus there are certain desiderata which have not been fully met by prior art devices. The apparatus should be small, panticularly with respect to diameter so that the problems of subcutaneous positioning are minimized. The number of parts should be minimal and the overall design made as simple as possible since valve failure necessitates another operation. Most important, the interior of the apparatus should provide no inactive cavities where hostile organisms may breed and provide no lodging places for foreign matter. Finally, the hydraulic design of the apparatus should be such that no eddies are present under flow conditions.

Accordingly, it is an object of this invention to provide a unidirectional normally open r'low apparatus for establishing fluid communication between a source of cerebrospinal fluid and a point in the vascular system having a lower mean pressure than the source of cerebrospinal fluid. i

Another object of the invention is to provide a device of the above character which is small, both in diameter and overall size, which has few parts, which contains no inactive or stagnant fluid cavities and which causes no eddies in operation.

A further object of the invention is to provide a highly reliable unitary normally open check valve structure which contains no hydraulically inactive areas, which is economical to fabricate, which permits flow in one direction under very slight hydraulic gradients but which closes immediately upon reversal of how.

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Still another object of the invention is to provide an apparatus which can be used for pumping, to clear the surgical shunt or to check overall operation.

It is also an object of the invention to provide an apparatus which will not produce an inflammatory reaction or a neoplasm in the tissues in which it is implanted; which does not undergo any physical or chemical changes resulting in fragility, disintegration, kinking, discoloration or occlusion in operation; which remains soft, elastic and pliable in operation; and which will be unaffected by superheated steam such as is used for sterilization.

Additional objects of the invention are to provide a device which is simple and rugged in construction, reliable and dependable in operation, easy and economical to produce, and avoids the disadvantages of prior art constructions.

These and related objects of the invention will be apparent to those skilled in the art from a consideration of the description which follows when read in conjunction with the drawing wherein:

FIGURE 1 represents a perspective elevational view of a typical normally open check valve used in the apparatus.

FIGURE 2 represents a section taken on 2--2 of FIG- URE 1.

FIGURE 3 represents a fragmentary view, partly in section, of the entire apparatus.

FIGURE 4- is a diagrammatic representation of the application of the device in the establishment of a ventriculo-venous shunt.

Turning now to a detailed consideration of the figures, wherein like letters and numerals designate like parts, it will be noted that the apparatus A, includes a normally open inlet valve C, provided with a connector B, and a normally open outlet valve D, which may be provided with a stiffener E, as Well as a terminal connector F. Valves C and D, stifiener E, and portions of connectors B and F are encapsulated in the apparatus A.

FIGURES 1 and 2 illustrate a typical checlc valve of the invention. As shown, inlet valve C is illustrated but the construction of outlet valve D is identical. Valve C is preferably moulded in one piece of resilient plastic such as for example, silicone rubber (e.g. Dow Corning 13-2000 or X40146). This type of material is used throughout the apparatus unless otherwise indicated. Any plastic used in the apparatus must not produce an inflammatory reaction or a neoplasm in the tissues in which it is implanted; should not undergo any physical or chemical change that would result in fragility, disintegration, kinking, discoloration or occlusion; tubing made of the plastic should have the softness, elasticity and pliability of living tissue and remain unaffected by the motion of tissue planes.

Valve C is generally thimble shaped and circular in cross section and includes straight side wall portions 10 and 11. Portion id is foreshortene d and thickened as at inner lip 12 whereas portion 11 is elongated and thinned as at outer lip 13. As best seen in FIGURE 2, inner or lower lip 12 is provided with a smooth internal radius 14 and a fiat internal face 115. Wall thickness or foreshortened lip 12 is obviously greater than thickness at portion it but all transitions are achieved with smooth curves, fillets and rounds so as to permit scouring action as fluid flows through the body. Wall thickness of elongated upper or outer lip 13 is decreased compared to sidewall portion 11 and an internal radius 16 is provided for smooth transition. Upper lip 13 overlaps lower lip 12, preferably by about one third the diameter of the valve C. While both lips l2 and 13 are resilient, in the broad sense of the word, lip 13 is much more resilient than lip 12 because of its thinner section.

A generally rectangular slot or flow passageway 17 is provided between the lips, extending from the cored interior of the valve to the exterior, and constitutes the valve outlet. When'flow is in the direction shown by the arrows in FIGURES 1 and 2 (i.e. downstream), slot 17 remains open but on reversal of flow more resilient outer lip 13 abuts or juxtaposes lower lip 12 thereby sealing passageway 17. Exemplary, nonlimiting dimensions are as follows: width of slot 170.0625"; height of slot 170.00-5; overall length of valve C--'.4375"; largest outside diameter of valve C0.1l5; wall thickness at and Ill-0.025. The dimensions may be varied in particular valves designed for particular applications. Thus, if a rapid drainage valve is desired for a particular patient slot 17 may be enlarged.

Valve C is mounted on connector B which includes an upper sleeve 18, a lower sleeve 19 and an intermediate flange 20. Flange 20 is, in turn, provided with an upper shoulder 21 and a lower shoulder 22. Valve C is mounted on sleeve 18 so that it abuts shoulder 21 and is preferably cemented or otherwise permanently affixed to the connector. Connector B may be made of any suitable material including metals or plastics and may be irradiated or otherwise treated to sterilize fluids flowing through it. The internal diameter of the connectors should be maximized so as not to unduly restrict flow through the apparatus.

FIGURE 3 illustrates the assembly of the apparatus with the arrow indicating the direction of flow. Connector B and valves C and D, shown therein, have already been discussed above. Outlet check valve D may be provided with a stiffener E which includes a flange 23 and a shouldered integral sleeve 24 on which valve D is permanently mounted in the same manner 'as inlet valve C is mounted on connector B.

Valves C and D are longitudinally spaced apart and encapsulated in a length of resilient flexible tubing or conduit 25 which runs from shoulder 21 of connector B to connector F. The proximate end of the tubing is permanently cemented to flange 20* and, if desired, to portions of the sidewall of normally open check valve C as well. Another normally open check valve D is cemented in place within the conduit 25 by cementing flange 23 and, if desired, portions of the valve sidewall. The outlet or distal end of conduit 25 terminates at connector F. Obviously more than two valves may be used or, if the pumping action discussed below is not desired, even a single valve may be employed.

Connector F, which may be made of any suitable material including, for example, stainless steel or plastic includes a flange 30, an integral sleeve 31 on which tubing 25 is mounted in juxtaposition to a'face of flange 3t and an outer sleeve 32. The exterior of sleeve 32 may be corrugated as at 33 and the bore of the connector may be threaded as at 34 to aid in surgical procedures wherein a fish, threaded at one end, is used to position the apparatus within the body. Apparatus A is employed in connection with a catheter 36 which is mounted on sleeve 19 in juxtaposition to shoulder 22 of connector B. This connection may be permanently made with cement if desired. The distal end of the apparatus is provided with a shunt tube 37 which is mounted .on sleeve 32 and tied thereto with surgical thread at the time of the operation. How much of the shunt is preassembled by the surgeon and how much is done during the operation is a matter of choice.

FIGURE 4 is a simplified diagrammatic representation of the apparatus in use. It should be appreciated that nothing shown therein is actually visible, the entire shunt being located subcutaneously. Catheter 36 is connected through a trephined aperture 38 in the skull to a source of cerebral spinal fluid such as, for example, a lateral ventricle. The catheter in turn is connected to apparatus A which is positioned behind and somewhat beneath the ear. Outlet tube 37 is directed to the cir- .4 culatory system such as, for example, by having its distal end placed in the right atrium or by being connected to the internal jugular vein 39.

Normally the hydrostatic pressure in catheter 36 excoeds the venous pressure at 39 and flow will be into the circulatory system. Since the valves C and D are normally open (as compared to prior ant valves which were normally closed) only negligible hydraulic dilierentials, on the order of one or two millimeters of Water (i.e. enough to overcome friction losses) are required to cause flow. However, when venous pressure is temporarily elevated, as by coughing or straining, small reverse differential pressure will cause valves C and D to close, thus preventing reverse flow. The apparatus provides no inactive fluid pockets within which infection can develop and flow through the valves occurs without eddies. The apparatus may be cleared or checked by taking advantage of its pumping capabilities. If tubing 25 is compressed intermediate valves C and D (which may be done even after a subcutaneous implant) liquid will be displaced by pressure through outlet valve D, and inlet valve C will simultaneously close. Upon release of pressure the intermediate portion of the tubing will be refilled due to the reverse action of the valves.

Although the invention has been described in considerable detail, the description is intended to be illustrative rather than limiting since the invention may be variously embodied. Consequently, its scope is to be determined only by the appended claims.

Having described my invention, I claim:

1. Apparatus for draining cerebrospinal fluid into the circulatory system comprising a resilient conduit; catheter means for connecting the proximate end of said conduit to a source of cerebrospinal fluid; tubular means for connecting the distal end of said conduit to a point of discharge in the circulatory system having a mean hydraulic pressure less than that at the source of cerebrospinal fluid; a plurality of normally open check valves encapsulated by said conduit in longitudinally spaced apart relationship to each other, said valves being adapted to permit flow from proximate to distal end of said conduit but to prevent counter-flow; each of said normally open check valves comprising a tube of resilient material having a generally circular cross section, open at its inlet end, the outlet end being provided with overlapping flaps between the faces of which is a flow passage leading from the intenior of said tube to the exterior thereof, said passage being normally open but capable of being sealed upon the existence of a higher pressure without said tube than within it, said sealing occurring by virtue of juxtaposition of the faces of said flaps.

2. Apparatus for draining cerebrospinal fluid into the circulatory system comprising a resilient conduit; catheter means for connecting the proximate end of said conduit to a source of cerebrospinal fluid; tubular means for connecting the distal end of said conduit to a point of discharge in the circulatory system having a mean hydraulic pressure less than that at the source of cerebrospinal fluid; a pair of normally open check valves encapsulated by said conduit in longitudinally spaced apart relationship to each other, said valves being adapted to permit flow from proximate to distal end of said conduit but to prevent counterfiow therethrough; each of said normally open check valves comprising a generally thimble shaped tube of resilient material open at its inlet end and provided at its outlet end with a pair of integral overlapping flaps, a flow passageway between the faces of said flaps extending from the interior to the exterior of said valve, the faces of said flaps being normally spaced apart but in passageway sealing juxtaposition when a higher pressure exists without said tube than within.

3. The apparatus of claim 2 wherein said resilient means for connecting the proximate end of said conduit to a source of cerebrospinal fluid; tubular means for connecting the distal end of said conduit to a point of discharge in the circulatory system having a mean hydraulic pressure less than that at the source of cerebrospinal fluid; a pair of normally open check valves encapsulated by said conduit in longitudinally spaced apart relationship to each other, said valves being adapted to permit flow from proximate to distal end of said conduit but to prevent counter-flow therethrough; each of said valves comprising a generally thimble shaped tube of resilient material having an internal longitudinally extending core terminating at the closed end of said thimble in a flow passageway leading from interior to exterior of said valve, inner and outer integral overlapping flaps between which said flow passageway is located, said inner flap being less resilient than said outer flap, the faces of said flaps being normally spaced apart but in passageway sealing juxtaposition when pressure outside of said valve exceeds that within said core.

5. The apparatus of claim 4 wherein said resilient valve material is a silicone rubber.

6. In an apparatus for draining cerebrospinal fluid into the circulatory system including a resilient conduit; catheter means for connecting the proximate end of said conduit to a source of cerebrospinal fluid; tubular means for connecting the distal end of said conduit to a point of discharge in the circulatory system having a mean hydraulic pressure less than that of the source of cerebrospinal fluid; and a plurality of one-way check valves encapsulated by said conduit in longitudinally spaced apart relationship to each other, said valves being adapted to permit flow from proximal to distal end of said conduit, but to prevent counter-flow; the improvement which comprises providing valves each including a tube of resilient material having a generally circular cross section, open at its inlet, the outlet end being provided with integral overlapping flaps between the faces of which is a flow passage leading from the interior of said tube to the exterior thereof, said passage being normally open but capable of being sealed upon the existence of a higher pressure without said tube than within it, said sealing occurring by virtue of juxtaposition of the faces of said flaps.

7. In an apparatus for draining cerebrospinal fluid into the circulatory system including a resilient conduit; catheter means for connecting the proximal end of said conduit to a source of cerebrospinal fluid; tubular means for connecting the distal end of said conduit to a point of discharge in the circulatory system having a mean hydraulic pressure less than that at the source of cerebrospinal fluid; and a pair of one-way check valves encapsulated by said conduit in longitudinally spaced apart relationship to each other, said valves being adapted to permit flow from proximal to distal end of said conduit but to prevent counterflow therethrough; the improvement which comprises providing valves each of which includes a generally thimble shaped tube of resilient material open at its proximal end and provided at its distal end with a pair of integral overlapping flaps between the faces of which is provided a flow passageway, having a generally rectangular cross section, extending from the interior to the exterior of said valve, said flaps being normally spaced apart but having their faces in passageway sealing juxtaposition when a higher pressure exists without said tube than within.

8. The apparatus of claim 7 wherein said resilient valve material is silicone rubber.

9. In an apparatus for draining cerebrospinal fluid into the circulatory system including a resilient conduit; catheter means for connecting the proximal end of said conduit to a source of cerebrospinal fluid; tubular means for connecting the distal end of said conduit to a point of discharge in the circulatory system having a mean hydraulic pressure less than that at the source of cerebrospinal fluid; and a pair of one-way check valves encapsulated within said conduit in longitudinally spaced apart relationship to each other, said valves being adapted to permit flow from proximal to distal end of said conduit but to prevent counter-flow therethrough; the improvement which comprises providing valves each of which includes a generally thimble shaped tube of resilient material having an internal longitudinally extending core terminating at the distal end of said thimble in a flow passageway, of generally rectangular cross section, leading from interior to exterior of said tube; inner and outer integral overlapping flaps between which said flow passageway is located, said inner flap being less resilient than said outer flap, the faces of said flaps being normally spaced apart but in passageway sealing juxtaposition when pressure outside of said valve exceeds that within said core.

References Cited in the file of this patent UNITED STATES PATENTS 657,007 Richter Aug. 28, 1900 1,630,040 Vogt et a1 May 24, 1927 2,648,335 Chambers Aug. 11, 1953 2,661,764 Johnson et al. Dec. 8, 1953 2,841,166 Auzin July 1, 1958 2,867,213 Thomas Jan. 6, 1959 2,969,066 Holter et al. Jan. 24, 1961 3,020,913 Heyer Feb. 13, 1962 FOREIGN PATENTS 227,087 Australia Feb. 23, 1960 

1. APPARATUS FOR DRAINING CEREBRIOSPINAL FLUID INTO THE CIRCULARTORY SYSTEM COMPRISING A RESILIENT CONDUIT; CATHETER MEANS FOR CONNECTING THE PROXIMATE END OF SAID CONDUIT TO A SOURCE OF CEREBROSPINAL FLUID; TUBULAR MEANS FOR CONNECTING THE DISTAL END OF SAID CONDUIT TO A POINT OF DISCHARGE IN THE CIRCULATORY SYSTEM HAVING A MEAN HYDRAULIC PRESSURE LESS THAN THAT AT THE SOURCE OF CEREBROSPINAL FLUID; A PLURALITY OF NORMALLY OPEN CHECK VALVES ENCAPSULATED BY SAID CONDUIT IN LONGITUDINALLY SPACED APART RELATIONSHIP TO EACH OTHER, SAID VALVES BEING ADAPTED TO PERMIT FLOW FROM PROXIMATE TO DISTAL END OF SAID CONDUIT BUT TO PREVENT COUNTER-FLOW; EACH OF SAID NORMALLY OPEN CHECK VALVES COMPRISING A TUBE OF RESILIENT MATERIAL HAVING A GENERALLY CIRCULAR CROSS SECTION, OPEN AT ITS INLET END, THE OUTLET END BEING PROVIDED WITH OVERLAPPING FLAPS BETWEEN THE FACES OF WHICH IS A FLOW PASSAGE LEADING FROM THE INTERIOR OF SAID TUBE TO THE EXTERIOR THEREOF, SAID PASSAGE BEING NORMALLY OPEN BUT CAPABLE OF BEING SEALED UPON THE EXISTENCE OF A HIGHER PRESSURE WITHOUT SAID TUBE THAN WITHIN IT, SAID SEALING OCCURRING BY VIRTUE OF JUXTAPOSITION OF THE FACES OF SAID FLAPS. 